Adverse reactions to HIV vaccines : medical, ethical, and legal issues |
Pubbl/distr/stampa | Washington : Office of Technology Assessment |
Disciplina | 616.97/92061 |
Soggetto topico |
AIDS vaccines - United States
AIDS (Disease) - Vaccination - Complications HIV infections - Risk factors - United States Human experimentation in medicine - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Adverse Reactions to HIV Vaccines |
Record Nr. | UNINA-9910689358803321 |
Washington : Office of Technology Assessment | ||
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Lo trovi qui: Univ. Federico II | ||
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Biospecimen research : meeting basic human subjects protection requirements and communicating informational risks |
Pubbl/distr/stampa | [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2013 |
Descrizione fisica | 1 online resource (25 pages) : illustrations |
Soggetto topico |
Medical records - Access control - United States
Human experimentation in medicine - United States Privacy, Right of - United States Clinical trials - Access control - United States Preservation of organs, tissues, etc - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Biospecimen research |
Record Nr. | UNINA-9910707453303321 |
[Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2013 | ||
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Lo trovi qui: Univ. Federico II | ||
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Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services |
Autore | Nass Sharyl J. |
Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , 2014 |
Descrizione fisica | 1 online resource (92 pages) : illustrations |
Disciplina | 174.28 |
Soggetto topico |
Human experimentation in medicine - United States
Human experimentation in medicine - Moral and ethical aspects - United States Patients - Civil rights - United States |
ISBN |
0-309-30669-8
0-309-30667-1 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Introduction -- Current regulatory arena -- Common rule and HIPAA -- Shortcomings of current regulations and guidances -- Context -- Data deindentification -- Impediment to quality improvement and learning -- Varied interpretation -- Misaligned incentives -- Lack of harmonization with international standards -- Informed consent forms -- Informed consent process -- Consent tools -- Beyond consent -- HITECH -- Advanced notice of proposed rulemaking -- Patient perspectives on research protections -- Ethical challenges of genetic advances -- Patient consent for use of archived biospecimens -- Return of research results -- Clinically actionable findings -- Context matters -- Who pays -- Biospecimens from deceased participants -- The changing context of research and care -- Oversight in a learning health care system -- Oversight of pragmatic trials -- Multisite studies and IRB review -- Central IRBs -- New England Reliance Agreement -- Value of local IRBs -- Educational needs -- Research needs -- Wrap-up. |
Record Nr. | UNINA-9910787154803321 |
Nass Sharyl J.
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Washington, District of Columbia : , : National Academies Press, , 2014 | ||
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Lo trovi qui: Univ. Federico II | ||
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Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services |
Autore | Nass Sharyl J. |
Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , 2014 |
Descrizione fisica | 1 online resource (92 pages) : illustrations |
Disciplina | 174.28 |
Soggetto topico |
Human experimentation in medicine - United States
Human experimentation in medicine - Moral and ethical aspects - United States Patients - Civil rights - United States |
ISBN |
0-309-30669-8
0-309-30667-1 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Introduction -- Current regulatory arena -- Common rule and HIPAA -- Shortcomings of current regulations and guidances -- Context -- Data deindentification -- Impediment to quality improvement and learning -- Varied interpretation -- Misaligned incentives -- Lack of harmonization with international standards -- Informed consent forms -- Informed consent process -- Consent tools -- Beyond consent -- HITECH -- Advanced notice of proposed rulemaking -- Patient perspectives on research protections -- Ethical challenges of genetic advances -- Patient consent for use of archived biospecimens -- Return of research results -- Clinically actionable findings -- Context matters -- Who pays -- Biospecimens from deceased participants -- The changing context of research and care -- Oversight in a learning health care system -- Oversight of pragmatic trials -- Multisite studies and IRB review -- Central IRBs -- New England Reliance Agreement -- Value of local IRBs -- Educational needs -- Research needs -- Wrap-up. |
Record Nr. | UNINA-9910811817703321 |
Nass Sharyl J.
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Washington, District of Columbia : , : National Academies Press, , 2014 | ||
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Lo trovi qui: Univ. Federico II | ||
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Contemporary issues for protecting patients in cancer research : workshop summary / / Institute of Medicine (U.S.) ; Sharyl J. Nass and Margie Patlak, Rapporteurs National Cancer Policy Forum Board on Health Care Services |
Pubbl/distr/stampa | Washington, District of Columbia : , : National Academies Press, , 2014 |
Descrizione fisica | 1 online resource (92 pages) : illustrations |
Disciplina | 174.28 |
Soggetto topico |
Human experimentation in medicine - United States
Human experimentation in medicine - Moral and ethical aspects - United States Patients - Civil rights - United States |
Soggetto genere / forma | Electronic books. |
ISBN | 0-309-30667-1 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Record Nr. | UNINA-9910460146203321 |
Washington, District of Columbia : , : National Academies Press, , 2014 | ||
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Lo trovi qui: Univ. Federico II | ||
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FDA oversight of clinical investigators |
Pubbl/distr/stampa | [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2000 |
Descrizione fisica | 1 online resource (25 pages) : illustration |
Soggetto topico |
Human experimentation in medicine - United States
Clinical trials - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti |
Food and Drug Administration oversight of clinical investigators
Oversight of clinical investigators |
Record Nr. | UNINA-9910707660103321 |
[Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2000 | ||
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Lo trovi qui: Univ. Federico II | ||
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Final report of the Advisory Committee on Human Radiation Experiments |
Pubbl/distr/stampa | New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996 |
Descrizione fisica | 1 online resource (655 p.) |
Disciplina | 616.9897 |
Soggetto topico |
Human experimentation in medicine - United States
Radiotherapy - United States Nuclear medicine - United States Medical ethics - United States Radiation victims - United States Gene therapy - United States |
Soggetto genere / forma | Electronic books. |
ISBN | 0-19-977140-5 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Cover; Contents; Remarks; Preface; Introduction: The Atomic Century; PART I: Ethics of Human Subjects Research: A Historical Perspective; Overview; 1. Government Standards for Human Experiments: The 1940s and 1950s; 2. Postwar Professional Standards and Practices for Human Experiments; 3. Government Standards for Human Experiments: The 1960s and 1970s; 4. Ethics Standards in Retrospect; PART II: Case Studies; Overview; 5. Experiments with Plutonium, Uranium, and Polonium; 6. The AEC Program of Radioisotope Distribution; 7. Nontherapeutic Research on Children
8. Total-Body Irradiation: Problems When Research and Treatment Are Intertwined9. Prisoners: A Captive Research Population; 10. Atomic Veterans: Human Experimentation in Connection with Bomb Tests; 11. Intentional Releases: Lifting the Veil of Secrecy; 12. Observational Data Gathering; 13. Secrecy, Human Radiation Experiments, and Intentional Releases; PART III: Contemporary Projects; Overview; 14. Current Federal Policies Governing Human Subjects Research; 15- Research Proposal Review Project; 16. Subject Interview Study; Discussion of Part III PART IV: Coming to Terms with the Past, Looking Ahead to the FutureOverview; 17. Findings; 18. Recommendations; STATEMENT BY COMMITTEE MEMBER JAY KATZ; OFFICIAL DOCUMENTS; Executive Order; Charter; APPENDICES; Acronyms and Abbreviations; Glossary; A; B; C; D; E; F; G; H; I; L; M; N; P; R; T; U; X; Selected Bibliography; Public Comment Participants; A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them; Index; A; B; C; D; E; F; G; H; I; J; K; L; M; N; O; P; Q; R; S; T; U; V; W; X; Y; Z |
Record Nr. | UNINA-9910453364603321 |
New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996 | ||
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Lo trovi qui: Univ. Federico II | ||
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Final report of the Advisory Committee on Human Radiation Experiments |
Pubbl/distr/stampa | New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996 |
Descrizione fisica | 1 online resource (655 p.) |
Disciplina | 616.9897 |
Soggetto topico |
Human experimentation in medicine - United States
Radiotherapy - United States Nuclear medicine - United States Medical ethics - United States Radiation victims - United States Gene therapy - United States |
ISBN |
0-19-770717-3
0-19-977140-5 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Cover; Contents; Remarks; Preface; Introduction: The Atomic Century; PART I: Ethics of Human Subjects Research: A Historical Perspective; Overview; 1. Government Standards for Human Experiments: The 1940s and 1950s; 2. Postwar Professional Standards and Practices for Human Experiments; 3. Government Standards for Human Experiments: The 1960s and 1970s; 4. Ethics Standards in Retrospect; PART II: Case Studies; Overview; 5. Experiments with Plutonium, Uranium, and Polonium; 6. The AEC Program of Radioisotope Distribution; 7. Nontherapeutic Research on Children
8. Total-Body Irradiation: Problems When Research and Treatment Are Intertwined9. Prisoners: A Captive Research Population; 10. Atomic Veterans: Human Experimentation in Connection with Bomb Tests; 11. Intentional Releases: Lifting the Veil of Secrecy; 12. Observational Data Gathering; 13. Secrecy, Human Radiation Experiments, and Intentional Releases; PART III: Contemporary Projects; Overview; 14. Current Federal Policies Governing Human Subjects Research; 15- Research Proposal Review Project; 16. Subject Interview Study; Discussion of Part III PART IV: Coming to Terms with the Past, Looking Ahead to the FutureOverview; 17. Findings; 18. Recommendations; STATEMENT BY COMMITTEE MEMBER JAY KATZ; OFFICIAL DOCUMENTS; Executive Order; Charter; APPENDICES; Acronyms and Abbreviations; Glossary; A; B; C; D; E; F; G; H; I; L; M; N; P; R; T; U; X; Selected Bibliography; Public Comment Participants; A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them; Index; A; B; C; D; E; F; G; H; I; J; K; L; M; N; O; P; Q; R; S; T; U; V; W; X; Y; Z |
Record Nr. | UNINA-9910791600903321 |
New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996 | ||
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Lo trovi qui: Univ. Federico II | ||
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Final report of the Advisory Committee on Human Radiation Experiments |
Pubbl/distr/stampa | New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996 |
Descrizione fisica | 1 online resource (655 p.) |
Disciplina | 616.9897 |
Soggetto topico |
Human experimentation in medicine - United States
Radiotherapy - United States Nuclear medicine - United States Medical ethics - United States Radiation victims - United States Gene therapy - United States |
ISBN |
0-19-770717-3
0-19-977140-5 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
Cover; Contents; Remarks; Preface; Introduction: The Atomic Century; PART I: Ethics of Human Subjects Research: A Historical Perspective; Overview; 1. Government Standards for Human Experiments: The 1940s and 1950s; 2. Postwar Professional Standards and Practices for Human Experiments; 3. Government Standards for Human Experiments: The 1960s and 1970s; 4. Ethics Standards in Retrospect; PART II: Case Studies; Overview; 5. Experiments with Plutonium, Uranium, and Polonium; 6. The AEC Program of Radioisotope Distribution; 7. Nontherapeutic Research on Children
8. Total-Body Irradiation: Problems When Research and Treatment Are Intertwined9. Prisoners: A Captive Research Population; 10. Atomic Veterans: Human Experimentation in Connection with Bomb Tests; 11. Intentional Releases: Lifting the Veil of Secrecy; 12. Observational Data Gathering; 13. Secrecy, Human Radiation Experiments, and Intentional Releases; PART III: Contemporary Projects; Overview; 14. Current Federal Policies Governing Human Subjects Research; 15- Research Proposal Review Project; 16. Subject Interview Study; Discussion of Part III PART IV: Coming to Terms with the Past, Looking Ahead to the FutureOverview; 17. Findings; 18. Recommendations; STATEMENT BY COMMITTEE MEMBER JAY KATZ; OFFICIAL DOCUMENTS; Executive Order; Charter; APPENDICES; Acronyms and Abbreviations; Glossary; A; B; C; D; E; F; G; H; I; L; M; N; P; R; T; U; X; Selected Bibliography; Public Comment Participants; A Citizen's Guide to the Nation's Archives: Where the Records Are and How to Find Them; Index; A; B; C; D; E; F; G; H; I; J; K; L; M; N; O; P; Q; R; S; T; U; V; W; X; Y; Z |
Record Nr. | UNINA-9910810920803321 |
New York, New York ; ; Oxford, [England] : , : Oxford University Press, , 1996 | ||
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Lo trovi qui: Univ. Federico II | ||
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Final report on low-volume institutional review boards |
Pubbl/distr/stampa | [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 1998 |
Descrizione fisica | 1 online resource (7, A-2, B-2 pages) : illustrations |
Soggetto topico |
Institutional review boards (Medicine) - United States - Evaluation
Human experimentation in medicine - United States |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Low-volume institutional review boards |
Record Nr. | UNINA-9910707660203321 |
[Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 1998 | ||
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Lo trovi qui: Univ. Federico II | ||
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